Dataset Information

An Autonomy-Supportive Online Decision Aid to Assist Smokers in Choosing Evidence-Based Cessation Assistance: Development Process and Protocol of a Randomized Controlled Trial.

ABSTRACT:

Background

Decision aids (DAs) may be used to facilitate an autonomous, informed decision to cease smoking and promote the uptake of evidence-based cessation assistance (ie, behavioral support, nicotine replacement therapy, or prescription medication). However, knowledge is lacking regarding their effective elements and (cost-)effectiveness.

Objective

We describe the development process of an online DA (called "VISOR") that helps smokers to choose evidence-based cessation assistance. Additionally, we provide a description of the protocol of an ongoing randomized controlled trial in which the DA containing an explicit value clarification method (VCM) and tailored advice is compared with a DA without an explicit VCM and tailored advice.

Methods

The development of "VISOR" was based on the International Patient Decision Aid Standards guidelines. Viewpoints of end users (collected through 20 interviews with smokers) and clinical and scientific experts (assessed using 2 Delphi studies with 24 scientists and 38 clinicians) were assessed regarding cessation tool decision making and preferred DA content. These findings, together with principles from the Self-Determination Theory, served as input for the development of the online DA. A first DA prototype was alpha-tested in September 2019 and beta-tested for usability in December 2019; feedback was incorporated and resulted in a final version. The final DA contains (1) an information section, (2) an optional knowledge quiz, (3) a brief smoking assessment, (4) intuitive decision, (5) intermediate advice, (6) an explicit VCM, (7) tailored advice, and (8) access information. A randomized controlled trial is currently being conducted to assess the DA's (cost-)effectiveness compared to a DA that does not include the explicit VCM and the tailored advice; specifically, the DA's effect on smoking abstinence, uptake of evidence-based cessation assistance, smoking abstinence mediated through uptake of evidence-based cessation assistance, and decisional conflict are investigated. Participants are randomly allocated to receive access to 1 of the 2 DAs and are asked to complete 5 questionnaires (including the baseline questionnaire) over a period of 12 months. To evaluate the effects of the DA on the outcome measures, logistic and linear regression analyses as well as mediation analyses will be carried out. An economic evaluation will be performed to assess the cost-effectiveness.

Results

Data regarding the effect of the VISOR DA are currently being collected, and data collection is expected to be concluded in 2021.

Conclusions

By making use of an iterative process that integrated different stakeholders' perspectives (including end users), we were able to systematically design an evidence-based DA. The study will contribute to the current knowledge regarding smoking cessation DA application, the added value of explicit VCMs, and the effect of behavioral and informed decision-making outcomes.

Trial registration

Netherlands Trial Register NL8270; https://www.trialregister.nl/trial/8270.

International registered report identifier (irrid)

DERR1-10.2196/21772.

SUBMITTER: Gultzow T

PROVIDER: S-EPMC7772073 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

An Autonomy-Supportive Online Decision Aid to Assist Smokers in Choosing Evidence-Based Cessation Assistance: Development Process and Protocol of a Randomized Controlled Trial.

Gültzow Thomas T Smit Eline Suzanne ES Hudales Raesita R Knapen Vera V Rademakers Jany J Dirksen Carmen D CD Hoving Ciska C

JMIR research protocols 20201215 12

<h4>Background</h4>Decision aids (DAs) may be used to facilitate an autonomous, informed decision to cease smoking and promote the uptake of evidence-based cessation assistance (ie, behavioral support, nicotine replacement therapy, or prescription medication). However, knowledge is lacking regarding their effective elements and (cost-)effectiveness.<h4>Objective</h4>We describe the development process of an online DA (called "VISOR") that helps smokers to choose evidence-based cessation assistan ...[more]

PMID: 33320096

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Project description:BackgroundPatient decision aids (PtDAs) support patients and clinicians in shared decision-making (SDM). Real-world outcome information may improve patients' risk perception, and help patients make decisions congruent with their expectations and values. Our aim was to develop an online PtDA to support kidney failure treatment modality decision-making, that: 1) provides patients with real-world outcome information, and 2) facilitates SDM in clinical practice.MethodsThe International Patient Decision Aids Standards (IPDAS) development process model was complemented with a user-centred and convergent mixed-methods approach. Rapid prototyping was used to develop the PtDA with a multidisciplinary steering group in an iterative process of co-creation. The results of an exploratory evidence review and a needs-assessment among patients, caregivers, and clinicians were used to develop the PtDA. Seven Dutch teaching hospitals and two national Dutch outcome registries provided real-world data on selected outcomes for all kidney failure treatment modalities. Alpha and beta testing were performed to assess the prototype and finalise development. An implementation strategy was developed to guide implementation of the PtDA in clinical practice.ResultsThe 'Kidney Failure Decision Aid' consists of three components designed to help patients and clinicians engage in SDM: 1) a paper hand-out sheet, 2) an interactive website, and 3) a personal summary sheet. A 'patients-like-me' infographic was developed to visualise survival probabilities for each treatment modality on the website. Other treatment outcomes were incorporated as event rates (e.g. hospitalisation rates) or explained in text (e.g. the flexibility of each treatment modality). No major revisions were needed after alpha and beta testing. During beta testing, some patients ignored the survival probabilities because they considered these too confronting. Nonetheless, patients agreed that every patient has the right to choose whether they want to view this information. Patients and clinicians believed that the PtDA would help patients make informed decisions, and that it would support values- and preferences-based decision-making. Implementation of the PtDA has started in October 2020.ConclusionsThe 'Kidney Failure Decision Aid' was designed to facilitate SDM in clinical practice and contains real-world outcome information on all kidney failure treatment modalities. It is currently being investigated for its effects on SDM in a clinical trial.

Project description:IntroductionIt has been estimated that smokers tend to fail to report unsuccessful quit attempts that lasted a short time and occurred a longer time ago. However, it is unclear whether the failure to report unsuccessful quit attempts varies by the type of cessation aid used.MethodsA total of 5,892 smokers aged 16+ years who had made 1+ quit attempts in the past year were surveyed between January 2014 and December 2020 as part of the Smoking Toolkit Study. Respondents indicated when their most recent quit attempt started, how long it lasted, and which cessation aid(s) were used (e.g., unaided, varenicline, and behavioural support). The percentage failure to report for each cessation aid and 95% bootstrap confidence intervals (CIs) were estimated with an established method. Test for equality of proportions was performed to examine whether quit attempts lasting between one day and one week and that started >6 months ago failed to be reported at a different rate depending on the cessation aid used.ResultsWe estimated that after three months, 97% (95% CI = 96%-98%) of unaided quit attempts lasting less than one day, 80% (95% CI = 79%-81%) of those lasting between one day and one week, and 60% (95% CI = 59%-61%) of those lasting between one week and one month fail to be reported. Compared with unaided attempts, the estimated percentage failure to report quit attempts that lasted between one day and one week and that started >6 months ago was significantly lower for attempts involving behavioural support (92% of unaided attempts vs. 75% of attempts involving behavioural support, χ 2(1) = 9.29, p = 0.002). No other significant differences were detected.ConclusionsSmokers in England appear to fail to report a substantial proportion of unsuccessful quit attempts. This failure appears particularly prominent for attempts that last a short time or occurred longer ago and appears lower for attempts involving behavioural support compared with unaided attempts.

Dataset Information

An Autonomy-Supportive Online Decision Aid to Assist Smokers in Choosing Evidence-Based Cessation Assistance: Development Process and Protocol of a Randomized Controlled Trial.

Background

Objective

Methods

Results

Conclusions

Trial registration

International registered report identifier (irrid)

Publications

An Autonomy-Supportive Online Decision Aid to Assist Smokers in Choosing Evidence-Based Cessation Assistance: Development Process and Protocol of a Randomized Controlled Trial.

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